REXALL ALOE- selenium sulfide liquid 
DOLGENCORP INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENT

SELENIUM SULFIDE 1%

PURPOSE

ANTI-DANDRUFF

USES

FOR THE RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE.

WARNINGS

FOR EXTERNAL USE ONLY.

ASK A DOCTOR BEFORE USE IF YOU HAVE

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP.

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

SHAKE WELL, APPLY SHAMPOO, AND RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

WATER (AQUA), AMMONIUM LAURYL SULFATE, AMMONIUM LAURETH SULFATE, DIHYDROGENATED TALLOW PHTALIC ACID AMIDE, COCAMIDE DEA, FRAGRANCE (PARFUM), TITANIUM DIOXIDE, DIMETHICONE, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM ISOSTEAROYL LACTYLATE, DMDM HYDANTOIN, ALOE BARBADENSIS LEAF JUICE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1 (CI 42090).

IMAGE OF THE LABEL

REXALL  ALOE
selenium sulfide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-616
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-616-11325 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/25/2012
Labeler - DOLGENCORP INC. (068331990)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55910-616)

Revised: 9/2012
Document Id: 507d84cf-5de8-49e8-9124-b22a91417e04
Set id: de36c704-5e37-4407-8335-2dbe8a38ebf3
Version: 1
Effective Time: 20120925
 
DOLGENCORP INC.